a study of intermittent oral dosing of asp1517 in erythropoieses stimulating agent (esa)-naive hemodialysis chronic kidney disease patients with anemia

Conditions: ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

Summary: the objective of this study is to evaluate the safety and efficacy of asp1517 in esa-naive hemodialysis chronic kidney disease patients with anemia.


Eligibility criteria:
inclusion criteria: * mean of the subjects' two most recent hb values during the screening period must be ≤10.0 g/dl with an absolute difference ≤1.0 g/dl between the two values * either transferrin saturation (tsat) ≥ 5% or serum ferritin ≥ 30 ng/ml during the screening period * female subject must either: be of non-childbearing potential: * post-menopausal (defined as at least 1 year without any menses) prior to screening, or * documented surgically sterile or, if of childbearing potential, * agree not to try to become pregnant during the study and for 28 days after the final study drug administration * and have a negative pregnancy test at screening * and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and continued for 28 days after the final study drug administration. * female subject must agree not to breastfeed starting at screening and throughout the study period, and continued for 28 days after the final study drug administration. * female subject must not donate ova starting at screening and throughout the study period, and continued for 28 days after the final study drug administration. * male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study period, and for 12 weeks after the final study drug administration * male subject must not donate sperm starting at screening and throughout the study period and, for 12 weeks after the final study drug administration exclusion criteria: * concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment * concurrent autoimmune disease with inflammation that could impact erythropoiesis * history of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis * uncontrolled hypertension * concurrent congestive heart failure (nyha class iii or higher) * history of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment * positive for hepatitis b surface antigen (hbsag) or anti-hepatitis c virus (hcv) antibody at the screening assessment, or positive for human immunodeficiency virus (hiv) in a past test * concurrent other form of anemia than renal anemia * having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment * aspartate aminotransferase (ast), alanine aminotransferase (alt), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment * previous or current malignant tumor (no recurrence for at least 5 years is eligible.) * having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment * having undergone a kidney transplantation * having a previous history of treatment with asp1517. * history of serious drug allergy including anaphylactic shock * participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

Keywords: renal anemia roxadustat asp1517 hemodialysis